Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients

This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Neoplasm Metastasis
• Intervention / Treatment: Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100038
    • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
• Elderly women (age ≥ 65years)
• Failure or relapse from standard chemotherapy or unfit for chemotherapy
• Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Adequate bone marrow, liver and renal function;
• Estimated life expectancy of at least 3 months.

Exclusion Criteria:

• Serious or uncontrolled concurrent medical illness
• Uncontrolled primary and metastatic brain tumor
• History of second primary malignancies
• Having been enrolled in other clinical trials within a month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyclophosphamide alone; Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily.	Drug: Cyclophosphamide 50mg
Experimental: Cyclophosphamide plus letrozole for resistant patients; Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.	Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg
Experimental: Cyclophosphamide plus letrozole for treat-naive patients; Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.	Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg
Active Comparator: letrozole alone; Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily.	Drug: Letrozole 2.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival(PFS) of the subjects	Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects).	up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of each treatment regimen for the subjects	Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .	up to approximately 2 years
Evaluate the quality of life for the subjects in the each treatment regimen	Subjects complete questionnaire in every 8 weeks.	up to approximately 2 years
Compare disease control rate for the subjects	Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.	up to approximately 2 years

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimated): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Cyclophosphamide; Letrozole
• Other Study ID Numbers: LET+CTX